NCT04483973已完成2 期
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Study to Evaluate the Safety and Efficacy of SPI-1005 in Severe COVID-19 Patients
Sound Pharmaceuticals, Incorporated10 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2021年8月27日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 10
- 主要终点
- Number of participants with treatment-related adverse events
研究概览
简要总结
The study is a randomized, double-blind, placebo-controlled, dose escalation, multi-center clinical trial (RCT) of SPI-1005 in adult subjects with positive PCR test for novel SARS-CoV-2 (nCoV2) and severe symptoms of COVID-19 disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults ≥18 years of age
- •Positive nCoV2 PCR test by nasopharyngeal, oral, saliva, or respiratory sample
- •Clinical signs, symptoms, and respiratory status consistent with severe COVID-19
- •Score of 5-7 on the WHO Ordinal Scale
- •Onset of severe COVID-19 symptoms ≤7 days of study enrollment
- •Subject is in-patient at time of randomization to study treatment
- •Subject or legally authorized representative is willing and able to provide informed consent, and agrees for subject to comply with planned study procedures including reproductive requirements
排除标准
- •Female patients who are pregnant or breastfeeding.
- •Participation in another interventional investigational drug or device study concurrently or within 30 days prior to study consent.
- •Patients with impaired hepatic or renal function.
- •Subject has any other illness or condition that, in the opinion of the investigator, would prohibit the subject from participating.
研究组 & 干预措施
SPI-1005 400 mg BID
Active Comparator
Oral administration of SPI-1005 400 mg BID for 14 days, with 30-day follow-up
干预措施: Ebselen (Drug)
Placebo
Placebo Comparator
Oral administration of matching placebo BID for 14 days, with 30-day follow-up
干预措施: Placebo (Drug)
结局指标
主要结局
Number of participants with treatment-related adverse events
时间窗: 30 days
Number of Participants With Treatment-related Adverse Events
时间窗: 30 days
Number of participants with adverse events, categorized by Common Terminology Criteria for Adverse Events (CTCAE) grading for severity.
次要结局
- Degree of supplemental oxygen(30 days)
- Peripheral Oxygen Saturation (SpO2)(30 days)
- WHO Ordinal Scale(30 days)
研究者
研究点 (10)
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